Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules

NCT05556525 | Terminated Results DMC FDA Device

• 3 other identifiers: MKT_2021_lung_01NCI-2022-0766021-008276
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• First-pass Diagnostic Yield

  Calculated as the proportion of patients for which first-pass transbronchial needle aspiration during bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure.

  Baseline

Secondary Outcomes (1)

• Per-patient Diagnostic Yield

  Baseline to 12 months following procedure

Other Outcomes (1)

• Clinical Impact of Needle-based Confocal Laser Endomicroscopy (nCLE)

  Up to 12 months following procedure

Study Arms (2)

Arm I (EBUS TBNA)

ACTIVE COMPARATOR

Patients undergo robotic EBUS TBNA on study.

Procedure: Ultrasound-Guided Transbronchial Needle Aspiration

Arm II (EBUS TBNA, nCLE, fluorescein)

EXPERIMENTAL

Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study.

Other: Fluorescein; Device: Image-Guided Needle Confocal Laser Endomicroscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration

Interventions

Fluorescein OTHER

Given IV

Arm II (EBUS TBNA, nCLE, fluorescein)

Image-Guided Needle Confocal Laser Endomicroscopy DEVICE

Undergo nCLE

Arm II (EBUS TBNA, nCLE, fluorescein)

Ultrasound-Guided Transbronchial Needle Aspiration PROCEDURE

Undergo EBUS TBNA

Also known as: EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Arm I (EBUS TBNA); Arm II (EBUS TBNA, nCLE, fluorescein)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 21 years of age
• Suspected PPN
• Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension)
• Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document

You may not qualify if:

• Inability or non-willingness to provide informed consent
• Failure to comply with the study protocol
• Patients with known allergy for fluorescein or risk factors for an allergic reaction
• Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure
• Possibly pregnant, pregnant or breastfeeding women
• Patients with hemodynamic instability
• Patients with refractory hypoxemia
• Patients with a therapeutic anticoagulant that cannot be held for an appropriate interval before the procedure
• Patients who are unable to tolerate general anesthesia according to the anesthesiologist
• Patient undergoing chemotherapy
• The lesions are unable to be localized/confirmed by bronchoscopy
• The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician
• The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Sebastian Fernandez-Bussy
• Organization: Mayo Clinic

Fernandez-Bussy.Sebastian@mayo.edu

904-953-6320

Study Officials

• Sebastian Fernandez-Bussy, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters will be blinded to patient history and cytologic/pathologic diagnosis.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: May 12, 2023
• Primary Completion: June 3, 2024
• Study Completion: October 25, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-07

Locations

US (1)